The clarification by the government’s main medical research organization follows concerns from the medical and scientific community that the ICMR has set August 15 as the goal of developing a vaccine against coronaviruses and asking investigators to clinical trials to enroll participants before July 7.
The letter was written by the Director General of the ICMR, Dr. Balram Bhargava. While the timelines have been strongly questioned by the scientific community, the ICMR said that the effort was to accelerate recruitment for human trials and that “the process exactly meets globally accepted standards for accelerate the development of the vaccine against pandemic-prone diseases in which human and animal trials can continue in parallel ”.
Amar Jesani, editor of the Indian Journal of Medical Ethics and public health advocate, said, “First, I want the ICMR statement to be signed by its CEO because it is his letter to investigators of the vaccine that caused the storm. Most of the issues raised in this letter remain unanswered. The ICMR is silent on the chronology, the declaration does not mention August 15. How did they get there? Are they considering abandoning phase 3 trials? The DG must also apologize for threatening the institutions, the ethics committee and the scientific community by saying that failure to respect the timetable will attract action. ”
Biotechnology and ethics researcher Anant Bhan said: “It is good to see the ICMR clarify its intention to conduct the trial scientifically. However, concerns raised about deadlines, instructions to sites to comply have not been clarified, including on the ethical red flags they raise. ”